A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN (NATURAL HISTORY-HCV)

Phase 2 Completed 105 enrolled Ortho Biotech Products, L.P.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected subjects.

Timeline

Start: 2001-10
Primary completion: —
Completion: 2002-12

Publications

Results Balan V, Schwartz D, Wu GY, Muir AJ, Ghalib R, Jackson J, Keeffe EB, Rossaro L, Burnett A, Goon BL, Bowers PJ, Leitz GJ; HCV Natural History Study Group. Erythropoietic response to anemia in chronic hepatitis C patients receiving combination pegylated interferon/ribavirin. Am J Gastroenterol. 2005 Feb;100(2):299-307. doi: 10.1111/j.1572-0241.2005.40757.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	—	—
Subject	Ribavirin	Small molecule	—	—

A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN (NATURAL HISTORY-HCV)

Summary

Timeline

Publications

Drugs

Indications